Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496105
Recruitment Status : Unknown
Verified December 2011 by Mohamed Saied Eldin Elsafty, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : December 21, 2011
Last Update Posted : December 21, 2011
Information provided by (Responsible Party):
Mohamed Saied Eldin Elsafty, Ain Shams University

Brief Summary:
The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.

Condition or disease Intervention/treatment Phase
Drug Usage Drug: Lidocaine Drug: saline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : July 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: lidocaine spray 10% Drug: Lidocaine
Placebo Comparator: Saline Drug: saline

Primary Outcome Measures :
  1. VAS score of Pain [ Time Frame: 5 minutes from lidocaine spraying ( after application of tenaculum) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-45
  • Speak Arabic or English

Exclusion Criteria:

  • History of cervical surgery
  • Known hypersensitivity to topical analgesics
  • First trimester abortion or miscarriage in the previous six weeks
  • Second trimester abortion or miscarriage in the previous 12 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01496105

Contact: Mohamed S.Eldin Elsafty, Lecturer +201003922211

Ain shams university hospital Recruiting
Cairo, Egypt
Contact: Mohamed Ibrahim Emeira, Lecturer    +201224456471   
Sponsors and Collaborators
Ain Shams University

Responsible Party: Mohamed Saied Eldin Elsafty, Lecturer of Obstetrics and Gynecology, Ain Shams University Identifier: NCT01496105     History of Changes
Other Study ID Numbers: ali elyan 2011
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action